AccessGUDID - DEVICE: Alethia Malaria (00840733102240)

GUDID

Device Identifier (DI) Information

Brand Name: Alethia Malaria
Version or Model: 480925
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 480925
Company Name: MERIDIAN BIOSCIENCE, INC.

Primary DI Number: 00840733102240
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092815364 *Terms of Use

Device Description: The Alethia Malaria amplification assay, performed on the Alethia Incubator/Reader, is a qualitative in vitro diagnostic test for the direct detection of Plasmodium sp. DNA in human venous EDTA whole blood specimens from individuals with signs and symptoms of malarial infection. Results from Alethia Malaria assays are intended to be used as an aid in the diagnosis of human malaria infection. Alethia Malaria assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Plasmodium sp. DNA by targeting segments of the Plasmodium genome. Alethia Malaria assay does not distinguish between Plasmodium species. Alethia Malaria is intended for use in hospital, reference or state laboratory settings. The device is not intended for nonlaboratory point-of-care use.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
52319	Multiple Plasmodium species nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple species of Plasmodium (malaria parasites) in a clinical specimen, using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAX	Plasmodium Spp. Detection Reagents

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 05c8f084-93ba-4913-97eb-8f1715c0ba02
Public Version Date: November 03, 2020
Public Version Number: 1
DI Record Publish Date: October 26, 2020